- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
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Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Serum concentrations in preterm infants with ROP after a dose of 0.2 mg (per eye), are higher than those observed in adult patients with neovascular AMD administered 0.5 mg in one eye. A population pharmacokinetics analysis shows that the Cmax is about 16 -fold higher and AUC about 12-fold higher than in adult patients. The apparent systemic half-life was about 6 days. A PK/PD analysis showed no clear relationship between systemic ranibizumab concentrations and systemic VEGF concentrations.
[Source SmPC Lucentis]
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
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Available formulations
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Dosages
| Retinopathy of prematurity (ROP) |
|---|
|
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Renal impaiment in children > 3 months
No information available on dose adjustment in renal impairment.
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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects in children
Ocular side effects: retinal hemorrhage and conjunctival hemorrhage.
Non-ocular side effects: nasopharyngitis, anemia, cough, urinary tract infection and allergic reactions.
Adverse reactions established for adult indications are considered applicable to preterm infants with ROP.
Long-term safety in preterm infants with ROP was investigated up to age 5 years in the RAINBOW extension study in which no new safety signals were demonstrated. The safety profile of ranibizumab 0.2 mg during the extension study was consistent with the safety profile observed in the main study at 24 weeks.
[Source SmPC Lucentis]
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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications
No information available on specific contra indications in children.
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Warnings & precautions in children
Intravitreal injection and reactions: Monitor the patient in the week following the intravitreal injection so that early treatment is possible if infection occurs. Instruct the patient to report possible symptoms of endophthalmitis or other reactions related to the intravitreal injection (intraocular inflammation, vitreous hemorrhage, retinal detachment and/or tear, traumatic cataract) immediately. In doing so, have immediate contact with the following symptoms: eye pain or increased discomfort, worsening of eye redness, blurred or reduced vision, increased number of small particles in vision, or increased sensitivity to light. Immunogenicity due to antibody formation may manifest as an increase in the severity of intraocular inflammation.
Monitor intraocular pressure and optic nerve perfusion, in relation to the possible occurrence of increase in intraocular pressure within 1 hour of injection. Persistent increase in intraocular pressure has also been observed. Do not inject ranibizumab if intraocular pressure is ≥ 30 mmHg.
Discontinue treatment or do not initiate treatment in the event of:
- a decrease in best corrected visual acuity (BCVA) of ≥ 30 letters compared with the last assessment;
- retinal rupture;
- with regmatogenous retinal detachment or stage 3 or 4 macular holes discontinue treatment;
- a subretinal hemorrhage in the center of the fovea óif the hemorrhage is ≥ 50% of the total lesion area;
- an intraocular pressure ≥ 30 mmHg;
- an intraocular surgical procedure within the past or next 28 days.
Use caution
- with risk factors for tears in the retinal pigment epithelium (RPE), such as detachment of the RPE sheet of large size and/or high intensity;
- with a history of stroke, TIA or myocardial infarction because of the risk of arterial thromboembolism. There are relatively few data on safety when treating these patients with intravitreal VEGF inhibitors.
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| Antineovascularisation agents | ||
|---|---|---|
| S01LA05 | ||
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Reference
- Novartis Europharm Limited, SmPC Lucentis (EU/1/06/374/002) Rev 42; 21-03-2023, www.ema.europa.eu
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Changes
Changes
